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Postdoctoral Staff Fellow: Pharmacology/Toxicology Reviewers

Company name
Center for Biologics Evaluation and Research, FDA

Silver Spring, MD

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POSTDOCTORAL STAFF FELLOW: PHARMACOLOGY/TOXICOLOGY REVIEWERS Office of Tissues and Advanced Therapies (OTAT) Center for Biologics Evaluation and Research (CBER) FOOD AND DRUG ADMINISTRATION (FDA) Department of Health and Human Services (HHS) The Pharmacology/Toxicology Branches in the Division of Clinical Evaluation and Pharmacology/ Toxicology in the Office of Tissues and Advanced Therapies are seeking outstanding scientists and biomedical engineers with training and/or experience in pharmacological, toxicological, biological, and/or veterinary sciences to join our team of Scientific Reviewers. Involvement in research projects investigating tissue-engineered, stem cell therapy, and/or gene therapy products, and experience conducting experiments in animals is beneficial. The Pharmacology/Toxicology Branches are responsible for review of a wide variety of advanced therapies, including stem cell and stem cell-derived products, functionally-mature and differentiated cells, gene therapies, products for xenotransplantation, blood- and plasma-derived products, and combination products.  The scientist or engineer will serve as the pharmacology/toxicology expert on a multidisciplinary review team that typically consists of product, clinical, and pharmacology/toxicology reviewers. Their primary responsibility will be the evaluation of preclinical data (e.g., in vitro and animal studies) during premarket review of investigational products. The pharmacology/toxicology reviewer provides feedback to sponsors regarding the design of their preclinical development program prior to investigational submissions. Additionally, they will review the preclinical data in investigational regulatory submissions to determine if there is adequate support for the rationale and safety of product administration in the proposed clinical population. The reviewer is also responsible for the review of the nonclinical sections of Biologics License Applications (BLAs) and Premarket Approval (PMA) applications. The regulatory reviews require written analyses and recommendations, as well as verbal communication of recommendations. Presentation at various scientific meetings is also an important aspect of the position. These positions will be filled through FDA's Service Fellowship program. The appointment is for up to four years with opportunities for renewal. Applications will be accepted from all groups of qualified persons, including non-citizens. No previous Federal experience is required. Appointment does not confer any entitlement to a position in the competitive service, and there is no entitlement to Merit Systems Protection Board (MSPB) appeals rights.

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Center for Biologics Evaluation and Research, FDA

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